Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

A Prospective Clinical Study of the Effects of Panretinal Photocoagulation Delivered With a Multi-spot Photocoagulator on Retinal Sensitivity and Driving Eligibility in Patients With Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383772
• Other study ID #: MICM1005
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: April 30, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the risk of failing the visual field criteria to hold a driving license following retinal laser treatment delivered with a multi-spot photocoagulator.

Description:

Despite improvements in the management of diabetes, the incidence of severe diabetes -related eye disease remains high. Laser treatment (panretinal photocoagulation (PRP)) is the gold standard treatment for reducing the risk of visual loss. However, evidence suggests that PRP can be damaging on visual field function and thus jeopardize patients' eligibility to drive. In the UK, it is the patient's responsibility to inform the DVLA that they are receiving retinal laser.

With the use of a multi-spot Photocoagulator for application of PRP at Moorfields the investigators are in a unique position to assess the effects of laser applied with this new delivery system on visual fields in a detailed fashion. Thus providing more accurate advice on visual prognosis and visual field function and addressing the risk of losing the ability to drive.

All treatment-naive patients with severe diabetic retinopathy requiring bilateral retinal laser treatment will be identified. Following informed consent these patients will undergo baseline visual field testing which will be of a duration of approximately 30 minutes and complete a quality of life questionnaire. All patients will receive their laser treatment as part of standard clinical care via the multi-spot Photocoagulator which will require approximately four 20 minute sessions. At 6 months following the completion of treatment the patients will undergo repeat visual field testing as conducted at baseline and complete a quality of life questionnaire. The investigators hope to recruit 100 patients.

Analysis of visual fields will principally involve assessment of whether patients have met the UK driving standards on Estermann VF testing. A quantitative assessment of change in retinal sensitivity will be undertaken by comparing retinal sensitivity pre and post-PRP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of either sex aged 18 years or over.

• Diabetes mellitus (type 1 or type 2).

• Best corrected visual acuity (BCVA) > or equal 6/60 in both eyes.

• Requiring full bilateral PRP.

• No previous laser treatment.

• Subject cooperation sufficient for adequate visual field testing.

• Ability to return for regular study visits.

Exclusion Criteria:

• Co-existent ocular/systemic condition that may affect visual field.

• Visual acuity less than 6/60 that may affect accuracy of visual field test.

• Presence of vitreous haemorrhage.

• Intraocular surgery/other intervention anticipated in either eye during the duration of treatment and VF assessment.

• Previous PRP.

• Age below 18.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Procedure:
• Pan retinal Photocoagulation
All patients with bilateral proliferative diabetic retinopathy requiring bilateral pan retinal photocoagulation will undergo baseline visual field tests prior to commencing laser treatment. These fields will be repeated at 6 months following completion of laser treatment.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust	Insulin Dependant Diabetes Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of failing visual field criteria to hold a driving licence.	All patients requiring bilateral PRP will be identified. These patients will undergo binocular and uniocular full-field static and kinetic visual field testing; All patients will receive their PRP via the multi-spot Photocoagulator using standardised parameters for treatment.; At 6 months following the completion of PRP the patients will undergo repeat visual field testing as conducted at baseline.; Analysis of visual fields will principally involve qualitative assessment of whether patients have met the UK driving standards on Estermann VF testing.	visual fields at baseline and at 6 months.	No
Secondary	Visual field assessment prior to planned pan retinal photocoagulation	Evaluation of full-field retinal sensitivity with visual field tests in patients with severe pre-proliferative or proliferative DR prior to planned PRP.; A quantitative assessment of retinal sensitivity using the mean global retinal sensitivity and measuring the entire hill-of-vision.; This will also be addressed at 6 months following PRP to compare to pre- treatment values.	at baseline	No